510(k) · Cleared

Cleared

Augease Vascular Augmentation Device

K101355510(k) TraditionalCleared Oct 26, 2010165-day reviewClass II21 CFR 870.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Augdvt, LLC · JOW Sleeve, Limb, Compressible

Cleared on Oct 26, 2010 as substantially equivalent to K903894 (Aci Medical, Inc., 1991) after a 165-day review. Its family tree reaches back 1 generation to 1991.

Decided: Oct 26, 2010
Review: 165 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K903894 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK903894 Venapulse Models VP-25 and VP-50Aci Medical, Inc. · 1991
This deviceK101355 Augease Vascular Augmentation DeviceAugdvt, LLC · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903894	Venapulse Models VP-25 and VP-50	Aci Medical, Inc.	1991	—
0 (this device)	K101355	Augease Vascular Augmentation Device	Augdvt, LLC	2010	—

FIG. 1 — Lineage of K101355, 1991–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOW device

#1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K903894	Venapulse Models VP-25 and VP-50 Summary page 3 …KiwS'W5 P92o44 510(k) Number K101355 K903894 Classification Compressible Limb-Sl-eeve ~ Compressible Limb Sleeve Product Code JOW…	Aci Medical, Inc.	1991	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · JOW

7in 2025

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	66	0	12
2008	4	112	7	36
2009	3	84	0	45
2010	18	71	2	66
2011	11	104	3	50
2012	13	63	2	100
2013	17	94	0	169
2014	16	91	0	93
2015	10	160	0	137
2016	9	121	0	150
2017	9	116	1	149
2018	11	136	0	114
2019	11	88	1	102
2020	14	158	0	50
2021	16	132	0	34
2022	7	80	0	27
2023	6	160	0	57
2024	8	197	0	30
2025	7	168	0	24
2026	6	252	0	—

What is it indicated for?

The AugEase™ is a foot actuated augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing. It is indicated as an accessory to an ultrasound imaging machine with or without Doppler which may be used for:

Distal augmentations

Proximal augmentations

Reflux measurements of specific venous valves

Vein Mapping

Locating suitable distal vessel for bypass

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101355 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101355: Augease Vascular Augmentation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101355

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026